Effect of Semi-sitting Position on Mask Ventilation

Effect of Semi-sitting Position on Mask Ventilation in Anesthetized and Paralyzed Patients

We compare the effect on semi-sitting position on mask ventilation in anesthetized and paralyzed obese patients

Study Overview

• Status: Completed
• Conditions: Ventilation
• Intervention / Treatment: Other: patient position

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • SMG-SNU Boramae Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Obese patients undergoing general anesthesia

Exclusion Criteria:

• diseases or structural abnormalities in the upper airway
• those who were at risk of aspiration
• cardiovascular or respiratory diseases
• pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Supine position; After the induction of anesthesia, mask ventilation is performed in the supine position.	Other: patient position; After the induction of anesthesia, mask ventilation is performed in the supine and semi-sitting position in a cross-over, randomized order.
Experimental: Semi-sitting position; After the induction of anesthesia, mask ventilation is performed in the semi-sitting position.	Other: patient position; After the induction of anesthesia, mask ventilation is performed in the supine and semi-sitting position in a cross-over, randomized order.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Expiratory tidal volume	Expiratory tidal volume is assessed during mask ventilation in the supine and semi-sitting positions.	1 minute after the induction of anesthesia

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Minute ventilation during mask ventilation in the supine and semi-sitting positions	Minute ventilation is assessed during mask ventilation	1 minute after anesthesia induction
The incidence of inadequate mask ventilation or dead space ventilation.	The incidence of inadequate mask ventilation or dead space ventilation is recorded.	during mask ventilation
Peak inspiratory pressure	Peak inspiratory pressure is recorded.	during mask ventilation

Collaborators and Investigators

• Sponsor: SMG-SNU Boramae Medical Center

Publications and helpful links

General Publications

• Chang JE, Seol T, Hwang JY. Body position and the effectiveness of mask ventilation in anaesthetised paralysed obese patients: A randomised cross-over study. Eur J Anaesthesiol. 2021 Aug 1;38(8):825-830. doi: 10.1097/EJA.0000000000001473.

Study record dates

Study Major Dates

• Study Start (Actual): March 9, 2020
• Primary Completion (Actual): June 8, 2020
• Study Completion (Actual): June 8, 2020

Study Registration Dates

• First Submitted: June 20, 2019
• First Submitted That Met QC Criteria: June 20, 2019
• First Posted (Actual): June 24, 2019

Study Record Updates

• Last Update Posted (Actual): June 11, 2020
• Last Update Submitted That Met QC Criteria: June 8, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 2019-1231

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No